In a controversial product liability case, Washington state’s highest court recently ruled that Eli Lilly and other drugmakers need not provide specific warnings to patients, in addition to the warnings they provide to prescribing physicians about drug side effects, even if a drug is advertised directly to patients.
The lawsuit in question involved David Dearinger, who suffered a stroke that left him permanently disabled less than two hours after taking Cialis, an erectile dysfunction drug from Lilly. Dearinger sued Lilly in federal court under Washington’s product liability law, claiming that Lilly knew or should have known that Cialis posed a risk of stroke to its users and failed to warn in a manner adequate users of this risk.
Part of Dearinger’s argument is that over time, the increased use of direct-to-consumer advertising by pharmaceutical companies has eroded the typical patient-doctor relationship and undermined patients’ dependence on physician expertise. .
But the Washington Supreme Court didn’t seem fazed by the argument and backed what’s known as the “learned middleman doctrine,” which has been around since 1978 and is used in every state and in Washington, DC Doctrine provides that drugmakers fulfill their duty to warn patients of the risks of their products if companies properly warn prescribing physicians.
“In short, Washington law effectively creates a presumption that a physician will exercise independent judgment in prescribing medication to a patient. The existence of direct-to-consumer advertising in no way alters a physician’s duties,” the ruling said. “By legal design, a physician must exercise independent judgment in prescribing drugs, and a consumer must rely on that judgment to obtain a prescription for a drug like Cialis.”
On whether Washington state law recognizes an exception to the learned intermediaries doctrine that requires prescription drug manufacturers to notify patients, not just prescribing physicians, when the manufacturer is directly consumer advertising, the court called Dearinger’s claims “largely unsubstantiated”, saying some of the papers and studies he cites “offer weak support for an exception that other courts have flatly rejected” .
“Washington law does not recognize an advertising exception to the learned intermediary doctrine,” said the ruling, backed by 7 court members. “In contrast, a drugmaker is protected under the learned intermediary doctrine even when it advertises directly to consumers, provided it gives adequate warnings to the prescribing physician. Of course, whether a warning is adequate remains a question of fact for a jury to decide. »
But two other justices, who also broadly agreed, challenged the majority’s “unsupported assumptions that all physicians ‘understand…complex information’ better than all patients. And I cannot agree with the consequence of this assumption, that it is better to hide complex information about their own health from patients than to reveal it to them in an understandable way. and sensible.